Registration Dossier

Administrative data

Description of key information

Not irritating to skin and eyes (standardized internal test methods similar to OECD Guideline 404 and 405; pre-GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptabel restrictions (occlusive, 20 h treatment, 2 animals, diluted substance (50%))
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 20 h treatment duration, 2 animals)
Principles of method if other than guideline:
Standardized internal test method (BASF test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Gaukler
- Weight at study initiation: female: 3.17 kg, male: 3.68 kg

ENVIRONMENTAL CONDITIONS: not reported
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated site of the same animal
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution
- Amount applied: no data

VEHICLE
- dest. water
Duration of treatment / exposure:
20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cotton pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water (possibly containing mild detergent)
- Time after start of exposure: 20 h

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
Yellow substance residues after 24 h and 8 days in both animals.
Slight scaling was observed in one animal during observation period.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 50 mg application amount, number of animals)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(reduced application volume, 72 h scoring not performed, number of animals)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.91 kg (female), 2.51 kg (male)

ENVIRONMENTAL CONDITIONS: not reported
Vehicle:
unchanged (no vehicle)
Controls:
other: talcum (amorph) into the other eye
Amount / concentration applied:
50 mg of test substance (100%)
Duration of treatment / exposure:
Single exposure without washing of the eyes.
Observation period (in vivo):
8 days (day 0, 1, 2, 5, 7 and 8)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL O TEST SUBSTANCE
- no

SCORING SYSTEM: evaluation was carried out according to the Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein at the end of the observation period
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
In the control eyes slight effects were seen, but these were fully reversible within 48 h.
Other effects:
yellow compound residues
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

The skin irritation potential of the test item was determined by application of a 50% aqueous solution onto skin of 2 rabbits (f/m) for 20h under occlusive conditions. Effects were scored 24, 48 and 72h after treatment and observed until day 8. The substance did not cause erythema or edema; a yellowish staining of the skin at the treatment site was recorded.

Eye:

To investigate the eye irritation potential of the test material, 50 mg of the compound were installed into one eye each of two rabbits (f/m). The eyes were not rinsed after treatment. The effects were scored 24 and 48h after installation, observation took place until day 8. The substance caused minimal conjunctival effects which were reversible within 48h. Moreover, yellow residues in or surround the eyes of the test animals were observed.

Results and discussion

Dermal application of the material onto skin did not cause formation of edema or erythema. Installation into eyes resulted in minimal, transient conjunctival effects. The test item is therefore not considered to be irritating to skin or eyes.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) No 2017/776.